MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKN REDAPT MONOBLOCK STEM PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU

Catalog Number UNKN01100102

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bacterial Infection (1735); Unspecified Infection (1930); Fluid Discharge (2686)

Event Date 01/04/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that after a medically indicated conversion of previous left hip surgery to total hip arthroplasty to repair a non union performed on (b)(6) 2015, where redapt modular slvd stem 240mm sz 19 was implanted, the patient experienced draining wound at distal aspect of hip incision. The wound was warm on touch and the patient had an infected picc line confirmed on blood test. An incision and drainage of a wound was planned 6 weeks after the surgery, but no confirmation was received. The patient continued having the draining wound and an overwhelming infection was reported 3 months postop. Device explantation was indicated, however a revision surgery was not confirmed. Additional details about primary surgery are unknown. Patient outcome is unknown. This de-identified clinical data is related to a post market clinical follow-up activity for redapt sleeved mono stems. As the data collection activity has been done retrospectively and data is provided anonymized, the information provided is limited and further information cannot be obtained.

• Brand Name: UNKN REDAPT MONOBLOCK STEM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 12524232
• MDR Text Key: 273078579
• Report Number: 1020279-2021-07126
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,study

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 10/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: UNKN01100102
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 10/19/2021
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 09/24/2021 Patient Sequence Number: 1